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510(k) K921402

Device
SURGICAL INSTRUMENT, DISPOSABLE
Applicant
MACRO MEDICAL, INC.
510(k) number
K921402
Product code
LXH  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-04
Date received
1992-03-24
Regulation
888.4540
Classification name
Orthopedic Manual Surgical Instrument
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SHERRY MCPHILLIPS
Address
5179 St. Imier Dr., Suite 100 Minneapolis MN US 55421 55421

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LXH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192873SX-One MicroKnifeSonex Health, Inc.2019-12-20
K140414IMBIBE NEEDLEOrthovita, Inc.2014-04-01
K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.2010-12-09
K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.2000-06-14
K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.1996-01-22
K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.1995-04-26
K944188SPINAL MARKERLeibinger L.P.1995-04-13
K941896STEADMAN LIGAMENT GRAFT PASSER AND PROTECTORDepuy, Inc.1994-11-07
K941711HYPERFLEX FLEXIBLE GUIDEWIRESLinvatec Corp.1994-08-26
K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHStryker Corp.1994-08-05
K933772PUNCH SURGICALMahe-Medizintechnik1994-02-01
K933242SOFAMOR ORTHOPAEDIC INSTRUMENTSDanek Medical, Inc.1994-01-28
K934260BARRIER BONE WAX APPLICATORPhillips Pharmaceuticals, Inc.1994-01-26
K931846BIO-PREPBiomedical Devices, Inc.1994-01-21
K930028CALMPS: BONE, MASTIN, LEWIN, BRANDThomasville Medical Assoc.1993-02-16

Legacy Summary#

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FDA Review#

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